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Waterhoudend contrast versus oliehoudend contrast voor het doorspuiten van de eileiders tijdens een baarmoederfoto - de lange termijn effecten.


- candidate number27568
- NTR NumberNTR6577
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jul-2017
- Secondary IDsVU University Medical Centre 2017.221
- Public TitleWaterhoudend contrast versus oliehoudend contrast voor het doorspuiten van de eileiders tijdens een baarmoederfoto - de lange termijn effecten.
- Scientific TitleOIL - BASED CONTRAST VERSUS WATER BASED CONTRAST MEDIA IN THE DIAGNOSIS OF TUBAL PATENCY AT HYSTEROSALPINGOGRAPHY: H2Oil trial long term follow-up.
- ACRONYMH2Oil long-term follow-up
- hypothesisThe primary hypothesis is that the effect of tubal flushing with oil-based contrast results in higher ongoing pregnancy rates compared to water-based contrast medium.
- Healt Condition(s) or Problem(s) studiedSubfertility, Hysterosalpingography
- Inclusion criteriaParticipants of the Water- versus Oil (H2Oil) study who were recruited in 27 hospitals (4 academic, 12 teaching and 11 non-teaching hospitals) in the Netherlands, between February 2012 and October 2014.

Inclusion criteria of the H2Oil study:
1. Age between 18 up to and including 39 years;
2. Subfertility of at least one year;
3. Chlamydia antibody titer (CAT) negative;
4. Low risk of tubal pathology according to the medical history;
5. Valid indication for HSG in the fertility work-up or before intra uterine insemination treatment.
- Exclusion criteriaExclusion criteria of the H2Oil study:
1. Endocrino-pathological diseases as: PCOS, Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type 1;
2. Known or high risk for tubal pathology, CAT positive;
3. Known contrast (iodine) allergy;
4. Male subfertility defined as a post-wash total motile sperm count < 3x10.6 spermatozoa/ml;
5. If not willing or able to sign the consent form.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jul-2017
- planned closingdate1-jul-2019
- Target number of participants1119
- InterventionsAfter given informed consent, women will be asked to fill in the questionnaire and return it.
- Primary outcomeOngoing pregnancy rate following HSG.
- Secondary outcomeBiochemical pregnancy, clinical pregnancy, miscarriage, ectopic pregnancy, multiple pregnancy, time from randomization to ongoing pregnancy, received fertility treatments, mode of conception, complications during pregnancy and delivery, neonatal outcomes, the aim and ability to get a second child, cost calculations of oil based contrast / water based contrast and assisted reproductive technology (ART) treatments.
- TimepointsFollow-up until 3 to 5 years after randomization.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. J. van Rijswijk
- CONTACT for SCIENTIFIC QUERIESDrs. J. van Rijswijk
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsDreyer K, van Rijswijk J, Mijatovic V, et al. Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile Women. N Engl J Med. 2017; May 25: 376:2043-2052.
Kieslinger DC, .. van Rijswijk J et al. Embryo selection using time-lapse analysis (Early Embryo Viability Assessment) in conjunction with standard morphology: a prospective two-center pilot study. Hum Reprod. 2016;31(11):2450-2457.
Becker JH, van Rijswijk J et al. Is intrapartum fever associated with ST-waveform changes of the fetal electrocardiogram? A retrospective cohort study. BJOG. 2012;119(11):1410-6.
- Brief summaryRecently, we published the H2Oil study: Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile women. The ongoing pregnancy rates within six monhts after randomization were 39.7% in the oil-group compared to 29.1% in the water-group. At six months, this difference between tubal flushing with lipiodol and water based contrast was still increasing. Firstly, it is unclear if this difference will increase beyond 6 months. Secondly, it is unclear if couples after having had a first child, still benefit from the single procedure of tubal flushing when they aim to get a second child. Thirdly, the economic impact of the use of oil-based contrast is unclear. It is likely that the 6 month difference in pregnancy rate will result in a decrease of the use of additional treatments, of which IVF is the most important one.
Based on these three questions, we propose a long-term follow-up of couples that participated in the H2Oil study.
- Main changes (audit trail)
- RECORD19-jul-2017 - 20-aug-2017


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